Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Sponsor Stanford University
Collaborator William E And Aenid R Weisgerber Foundation
Start date January 2007
Trial size 30 participants
Trial identifier NCT00449891, 1102002-100-GHATW, IRB 97517

Summary

This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional

Eligibility Criteria

Male or female participants from 3 years up to 10 years old.

Inclusion Criteria: Inclusion Criteria for study subjects: - To be between ages 3 to 10 years - Have been diagnosed with type 1 diabetes for at least 6 months; and - Do not have plans to move out of the area within the next 36 months. Inclusion Criteria for control subjects: - To be between ages 3 to 10 years Exclusion Criteria: - No history of head trauma with any loss of consciousness, - Cystic fibrosis, - Prematurity (born less than 30 weeks of gestation), - Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), - Neurologic disease independent of diabetes (eg seizure disorder); or - Medical contraindication to MRI procedure (eg metal appliances such as braces).

Additional Information

Official title Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
Principal investigator Tandy Aye, MD
Description In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Stanford University.